Design Assurance Engineers​/Systems Engineers; Hardware​/Software

Position Overview

We are seeking experienced Design Assurance Engineers and/or Systems Engineers (Hardware/Software) to support a comprehensive Design History File (DHF) gap assessment and remediation initiative. Contractors will evaluate design completeness, traceability, and risk alignment for existing medical devices, ensuring compliance with internal procedures and global regulatory requirements. This work requires deep expertise in design controls, risk documentation, verification/validation, and post‑market feedback integration.

On‑site location near Minneapolis, Minnesota. Duration – 6 months with potential extension.

• DHF Gap Assessment
• Review design documentation (user needs, system requirements, design inputs/outputs, verification, validation) for traceability, completeness, and alignment.
• Confirm requirements properly connect to:
• Hazard analyses
• Risk management files (e.g., DFMEA, FTA, HHEs)
• Risk controls and mitigations
• Evaluate verification and validation test methods to ensure they are appropriate, justified, and fully validated.
• Post‑Market & Field Signal Evaluation
• Assess whether existing design requirements and risk mitigations sufficiently address:
  • Complaint trends
  • Field actions
  • CAPA inputs
  • Known product signals
• Identify gaps where post‑market learnings should be incorporated into the design or risk documentation.
• Gap Remediation & Execution Support – Prioritize identified gaps and support remediation activities.
• Update or create new DHF documentation within internal systems.
• Participate in or lead cross‑functional reviews to ensure closure of identified gaps.

• Provide engineering support aligned to design controls, risk management processes, and post‑market quality activities.
• Ensure deliverables comply with internal SOPs and global regulations (FDA, ISO 13485, ISO 14971).
• Create, remediate, and finalize DHF documentation, ensuring all documentation is complete, accurate, audit‑ready, and traceable across the design lifecycle.
• Develop project timelines and manage assigned deliverables.
• Work closely with systems engineering, R&D, quality, and regulatory functions.
• Communicate progress, risks, and needs to stakeholders.
• Use quality tools and metrics to identify and execute process improvements across sustaining engineering or documentation workflows.
• Provide routine status updates and progress reports; participate in meetings, reviews, and project checkpoints.
• Flexibility to support additional engineering or documentation activities required to meet project objectives.

• 5+ years of experience in Systems Engineering, Quality Engineering, or Design Assurance in a regulated industry (medical devices strongly preferred).
• Strong understanding of:
  • Design controls (21 CFR 820.30 / ISO 13485)
  • Risk management (ISO 14971)
  • Verification & validation methodologies
  • Complex electro‑mechanical or software‑based systems
• Experience assessing or remediating DHFs, technical files, or risk files.
• Ability to analyze complex design architectures and trace requirements.
• Familiarity with post‑market quality systems (complaints, CAPA, field actions).
• Strong documentation and technical writing skills.

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.